Delivery System Having an Integral Centering Mechanism for Positioning a Valve Prosthesis in Situ

ABSTRACT

Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/108,192, filed Jan. 27, 2015, which is herebyincorporated by reference in its entirety for all purposes.

FIELD OF THE INVENTION

The invention relates to a delivery system and more particularly to adelivery system having an integral centering mechanism for positioning avalve prosthesis in situ.

BACKGROUND OF THE INVENTION

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrioventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent or scaffoldstructures that can be delivered percutaneously using a catheter-baseddelivery system have been developed for heart and venous valvereplacement. These prosthetic valves may include either self-expandingor balloon-expandable stent structures with valve leaflets attached tothe interior of the stent structure. The prosthetic valve can be reducedin diameter, by compressing onto a balloon catheter or by beingcontained within a sheath component of a delivery system, and advancedthrough the venous or arterial vasculature. Once the prosthetic valve ispositioned at the treatment site, for instance within an incompetentnative valve, the stent structure may be expanded to hold the prostheticvalve firmly in place. One example of a stented prosthetic valve isdisclosed in U.S. Pat. No. 5,957,949 to Leonhardt et al. entitled“Percutaneous Placement Valve Stent”, which is incorporated by referenceherein in its entirety. Another example of a stented prosthetic valvefor a percutaneous pulmonary valve replacement procedure is described inU.S. Patent Application Publication No. 2003/0199971 A1 and U.S. Pat.No. 8,721,713, both filed by Tower et al., each of which is incorporatedby reference herein in its entirety.

Although transcatheter delivery methods have provided safer and lessinvasive methods for replacing a defective native heart valve,complications may arise including vessel trauma due to percutaneousdelivery within highly curved anatomy and/or due to a large deliveryprofile of the prosthesis, inaccurate placement of the valve prosthesis,conduction disturbances, coronary artery obstruction, and/or undesirableparavalvular leakage and/or regurgitation at the implantation site. Moreparticularly, for example, a prosthesis that is positioned too deeprelative to the native annulus or placed unevenly within the nativeannulus in terms of depth may cause conduction disturbances. In anotherexample, if a prosthesis is not circumferentially centered relative tothe native annulus, the deployed prosthesis may dislodge from theimplantation site and/or undesirable paravalvular leakage and/orregurgitation may occur. Thus, it is imperative that the prosthesis beaccurately located relative to the native annulus prior to fulldeployment of the prosthesis.

Embodiments hereof are directed to a delivery system for a transcathetervalve prosthesis having an integral centering mechanism for positioninga valve prosthesis in situ to address one or more of the afore-mentionedcomplications.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to delivery systems for a valve prosthesisconfigured for delivery within a vasculature. In an embodiment hereof,the delivery system includes an outer shaft defining a lumen and atleast two windows formed through a sidewall thereof and an inner shaftconcentrically disposed within the lumen of the outer shaft. The innershaft has a distal portion being configured to receive the valveprosthesis thereon. The delivery system also includes at least onecentering mechanism including at least two wings. A first end of eachwing is attached to the inner shaft and a second end is free to slideover the inner shaft. When the centering mechanism is in a deliveryconfiguration each wing is offset from one of the windows of the outershaft and has a straightened profile that is enclosed between the outerand inner shafts. When the centering mechanism is in an expandedconfiguration each wing has a curved, bowed profile and is aligned withand radially extends through one of the windows of the outer shaft.

In another embodiment hereof, the delivery system includes an outershaft defining a lumen and at least one window formed through a sidewallthereof and an inner shaft concentrically disposed within the lumen ofthe outer shaft. The inner shaft has a distal portion being configuredto receive the valve prosthesis thereon, and the inner shaft isrotatable with respect to the outer shaft. The delivery system alsoincludes at least one centering mechanism including at least one coiledwing. A first end of the coiled wing is attached to the inner shaft anda second end is unattached to inner shaft. When the centering mechanismis in a delivery configuration the coiled wing has a series of windingsthat extend around the inner shaft such that each winding is enclosedbetween the outer and inner shafts. When the centering mechanism is inan expanded configuration the coiled wing extends through the window ofthe outer shaft and has a series of windings that extend around theouter shaft.

In another embodiment hereof, the delivery system includes an outermostshaft defining a central lumen and defining a plurality of lumens in asidewall thereof, a retractable outer shaft concentrically disposedwithin the central lumen of the outermost shaft, and an inner shaftconcentrically disposed within a lumen defined by the outer shaft. Theinner shaft has a distal portion being configured to receive the valveprosthesis thereon. The delivery system also includes a plurality ofelongated filaments slidingly positioned within the plurality of lumensof the outermost shaft. Each filament has at least a distal portionformed from a self-expanding material. When each elongated filament isin a delivery configuration the distal portion of each elongatedfilament has a straightened profile that is enclosed within one of thelumens in the sidewall of the outermost shaft. When each elongatedfilament is in an expanded configuration the distal portion of eachelongated filament has a curved, bowed profile and extends out of adistal end of the outermost shaft.

In another embodiment hereof, the delivery system includes an outermostshaft defining a central lumen and defining a plurality of lumens in asidewall thereof, a retractable outer shaft concentrically disposedwithin the central lumen of the outermost shaft, and an inner shaftconcentrically disposed within a lumen defined by the outer shaft. Theinner shaft has a distal portion being configured to receive the valveprosthesis thereon. The delivery system also includes a plurality ofelongated filaments slidingly positioned within the plurality of lumensof the outermost shaft. A distal end of each elongated filament isattached to an outer surface of the outer shaft. When each elongatedfilament is in a delivery configuration a distal portion of eachelongated filament has a straightened profile that is flush against theouter surface of the outer shaft. When each elongated filament is in anexpanded configuration the distal portion of each elongated filament hasa curved, bowed profile radially spaced apart from the outer surface ofthe outer shaft.

In another embodiment hereof, the delivery system includes an outershaft defining a lumen, the outer shaft including at least onepre-formed deflection segment formed thereon. The deflection segment hasa curved, bowed profile with respect to the remaining length of theouter shaft. The delivery system also includes an inner shaftconcentrically disposed within the lumen of the outer shaft. The innershaft has a distal portion being configured to receive the valveprosthesis thereon. The outer shaft is sufficiently flexible to deforminto a substantially straight configuration when percutaneouslyintroduced into a vasculature.

Another embodiment hereof relates to a tool for use with a deliverysystem for a valve prosthesis configured for delivery within avasculature. The tool includes a shaft component defining a lumen, theshaft component having a proximal end and a distal end. A handle iscoupled to the proximal end of the shaft component and a lever arm iscoupled to the distal end of the shaft component. The level arm has afirst end attached to an outer surface of the shaft component. When thelever arm is in a delivery configuration the second end of the lever armis detachably coupled to the outer surface of the shaft component andthe lever arm has a straightened profile that is flush against the outersurface of the shaft component. When the lever arm is in an expandedconfiguration the second end of the lever arm is detached from the shaftcomponent and the second end of the lever arm self-expands radially awayfrom the shaft component such that the lever arm forms an acute anglewith respect to the outer surface of the shaft component.

In another embodiment hereof, the delivery system includes an outermostshaft defining a central lumen, an outer shaft concentrically disposedwithin the central lumen of the outermost shaft, and an inner shaftconcentrically disposed within a lumen defined by the outer shaft. Theouter shaft is rotatable and slidable relative to the outermost shaft.The inner shaft has a distal portion being configured to receive thevalve prosthesis thereon. The delivery system also includes a pluralityof deployable loops, a first end of each loop being attached to a distalend of the outermost shaft and a second end of each loop being attachedto the outer shaft. When each loop is in a delivery configuration theloop has a straightened profile that is flush against the outer surfaceof the outer shaft. When each loop is in an expanded configuration theloop has a curved, bowed profile radially spaced apart from the outersurface of the outer shaft and also spirals with respect to the outershaft.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 is an illustration of a delivery system in situ.

FIG. 1A is a cross-sectional view taken along line A-A of FIG. 1.

FIG. 2 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism is in a deployed or expanded configuration.

FIG. 3 is a side view of a portion of the delivery system of FIG. 2,wherein the centering mechanism is in a delivery or unexpandedconfiguration.

FIG. 3A is a cross-sectional view taken along line A-A of FIG. 3.

FIG. 4 is a side view of a portion of the delivery system of FIG. 2,wherein the centering mechanism is in a deployed or expandedconfiguration.

FIG. 4A is a cross-sectional view taken along line A-A of FIG. 4.

FIG. 5 is a cross-sectional view of a delivery system having an integralcentering mechanism according to another embodiment hereof, wherein thecentering mechanism includes three circumferentially spaced wings andthe centering mechanism is in a delivery or unexpanded configuration.

FIG. 6 is a side view of a portion of a delivery system having anintegral centering mechanism according to another embodiment hereof,wherein translation deploys the centering mechanism and the centeringmechanism is in a delivery or unexpanded configuration.

FIG. 7 is a side view of a portion of the delivery system of FIG. 6,wherein the centering mechanism is in a deployed or expandedconfiguration.

FIG. 8 is a side view of a centering mechanism according to anotherembodiment hereof, the centering mechanism being removed from thedelivery system for illustrative purposes only, wherein the centeringmechanism is in a deployed or expanded configuration.

FIG. 9 is a side view of a portion of a delivery system according toanother embodiment hereof, wherein the delivery system includes groovesto assist in deployment of a centering mechanism.

FIG. 9A is a cross-sectional view taken along line A-A of FIG. 9.

FIG. 10 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism is in a deployed or expanded configuration.

FIG. 11 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism is a coiled wing and is shown in a deployed orexpanded configuration.

FIG. 12 is a perspective view of a portion of the delivery system ofFIG. 11, wherein the centering mechanism is primarily in a delivery orunexpanded configuration with only a first end thereof being deployed.

FIG. 12A is a perspective view of a portion of the delivery systemhaving an integral centering mechanism according to an embodiment hereofin situ, wherein the centering mechanism is a coiled wing with windingsthat longitudinally extend to form a conical profile and the centeringmechanism is primarily in a delivery or unexpanded configuration withonly a first end thereof being deployed.

FIG. 13 is a side view of the centering mechanism of FIG. 12, thecentering mechanism being removed from the delivery system forillustrative purposes only, wherein the centering mechanism is in adelivery or unexpanded configuration.

FIG. 14 is a perspective view of a portion of the delivery system ofFIG. 11, wherein the centering mechanism is in a deployed or expandedconfiguration.

FIG. 14A is a perspective view of a portion of the delivery system ofFIG. 12A, wherein the centering mechanism is in a deployed or expandedconfiguration.

FIG. 15 is a side view of the centering mechanism of FIG. 14, thecentering mechanism being removed from the delivery system forillustrative purposes only, wherein the centering mechanism is in adeployed or expanded configuration.

FIG. 16 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism includes a plurality of extendibleself-expanding filaments and is shown in a deployed or expandedconfiguration.

FIG. 16A is a cross-sectional view taken along line A-A of FIG. 16.

FIG. 17 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism includes a plurality of filaments that may beselectively bowed or expanded and is shown in a deployed or expandedconfiguration.

FIG. 18 is an illustration of a delivery system having an integralcentering mechanism according to an embodiment hereof in situ, whereinthe centering mechanism includes a plurality of extendibleself-expanding filaments with a soft, curled distal end and is shown ina deployed or expanded configuration.

FIG. 19 is a side view of a portion of the delivery system of FIG. 18.

FIG. 20 is an illustration of a delivery system in which an outer shaftthereof is pre-formed or pre-shaped to include a plurality of deflectionsegments according to another embodiment hereof in situ, wherein thedeflection segments are shown in a deployed or expanded configuration.

FIG. 20A is an illustration of a delivery system in which an outer shaftthereof is pre-formed or pre-shaped to include a plurality of deflectionsegments according to another embodiment hereof in situ, wherein thedeflection segments are shown in a deployed or expanded configurationand the deflection segments form a portion of a spiral or corkscrew.

FIG. 21 is a side view illustration of a delivery system having adeployable lever arm according to an embodiment hereof, wherein thelever arm is shown in a delivery or unexpanded configuration.

FIG. 21A is a top view illustration of a distal portion of the deliverysystem of FIG. 21, wherein the lever arm is shown in a delivery orunexpanded configuration.

FIG. 21B is a top view illustration of a distal portion of a deliverysystem having a deployable lever arm according to an embodiment hereof,wherein the lever arm is shown in a delivery or unexpandedconfiguration.

FIG. 22 is an illustration of the delivery system of FIG. 21 in situ,wherein the lever arm is shown in a deployed or expanded configuration.

FIG. 22A is a top view illustration of a distal portion of the deliverysystem of FIG. 21A, wherein the lever arm is shown in a deployed orexpanded configuration.

FIG. 22B is a top view illustration of a distal portion of the deliverysystem of FIG. 21B, wherein the lever arm is shown in a deployed orexpanded configuration.

FIG. 23 is an illustration of a delivery system having an integralcentering mechanism according to another embodiment hereof in situ,wherein the centering mechanism includes a plurality of deployable loopsand is shown in a deployed or expanded configuration.

FIG. 23A is a cross-sectional view taken along line A-A of FIG. 23.

FIG. 24 is a side view of a portion of an outer shaft, an outermostshaft, and the plurality of loops of FIG. 23, with the components beingshown removed from the delivery system of FIG. 23 for illustrationpurposes only, wherein the loops are shown in a straightened or deliveryconfiguration.

FIG. 25 is a side view of the components of FIG. 24 after relativerotation thereof.

FIG. 26 is a side view of the components of FIG. 24 after relativelongitudinal movement thereof.

FIG. 27 is a side view of the components of FIG. 24 after simultaneousrotation and longitudinal movement thereof.

FIG. 28 is a side view of the components of FIG. 24 after further oradditional simultaneous rotation and longitudinal movement thereof.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. Unless otherwise indicated,the terms “distal” and “proximal” are used in the following descriptionwith respect to a position or direction relative to the treatingclinician. “Distal” and “distally” are positions distant from or in adirection away from the clinician, and “proximal” and “proximally” arepositions near or in a direction toward the clinician. In addition, theterm “self-expanding” is used in the following description and isintended to convey that the structures are shaped or formed from amaterial that can be provided with a mechanical memory to return thestructure from a compressed or constricted delivery configuration to anexpanded deployed configuration. Non-exhaustive exemplary self-expandingmaterials include stainless steel, a pseudo-elastic metal such as anickel titanium alloy or nitinol, various polymers, or a so-called superalloy, which may have a base metal of nickel, cobalt, chromium, or othermetal. Mechanical memory may be imparted to a wire or scaffold structureby thermal treatment to achieve a spring temper in stainless steel, forexample, or to set a shape memory in a susceptible metal alloy, such asnitinol. Various polymers that can be made to have shape memorycharacteristics may also be suitable for use in embodiments hereof toinclude polymers such as polynorborene, trans-polyisoprene,styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer,oligo caprylactone copolymer and polycyclooctene can be used separatelyor in conjunction with other shape memory polymers. The term“substantially straight” and/or “straightened” is used in the followingdescription and is intended to convey that the structures are linearlyshaped or formed as a line within a tolerance of 5%.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of embodiments hereof are in thecontext of delivery systems for delivering a prosthetic heart valvewithin a native aortic valve, the delivery systems of the invention canalso be used in other areas of the body, such as for delivering aprosthetic heart valve within a native mitral valve, for delivering aprosthetic heart valve within a native pulmonic valve, for delivering aprosthetic heart valve within a native tricuspid valve, for delivering avenous valve, or for delivering a prosthetic heart valve within a failedpreviously-implanted prosthesis. Furthermore, there is no intention tobe bound by any expressed or implied theory presented in the precedingtechnical field, background, brief summary or the following detaileddescription.

FIGS. 1-1A illustrate a delivery system 100 that is configured forendoluminal transcatheter repair/replacement of a defective heart valve.Delivery system 100 is depicted in a delivery configuration in FIG. 1with a prosthetic heart valve (not shown) loaded within a distal capsulesection 102 of the delivery system. As shown in FIG. 1A, delivery system100 also includes a tubular outer shaft 106 defining a lumen 108there-through and a tubular inner shaft 110 defining a lumen 112there-through. A distal tip 104 is coupled to a distal end of innershaft 110. Inner shaft 110 is concentrically disposed within lumen 108of outer shaft 106, and lumen 112 of inner shaft 110 may be sized toslidingly receive a guidewire 114 such that delivery system 100 may betracked over the guidewire during delivery of the prosthetic heartvalve. In the delivery configuration of FIG. 1, distal capsule section102 is disposed over the prosthetic heart valve to compressively retainthe prosthetic heart valve in crimped engagement with inner shaft 110.Delivery system 100 may be one of, but is not limited to, the deliverysystems described in U.S. Patent Publication No. 2011/0245917 to Savageet al., U.S. Patent Publication No. 2011/0251675 to Dwork, U.S. PatentPublication No. 2011/0251681 to Shipley et al., U.S. Patent PublicationNo. 2011/0251682 to Murray, III et al., and U.S. Patent Publication No.2011/0264202 to Murray, III et al., each of which is herein incorporatedby reference in its entirety.

Although the prosthetic heart is not shown, it will be understood bythose of ordinary skill in the art that the prosthetic heart valveincludes a stent frame maintaining a valve structure (tissue orsynthetic) within the stent frame, the stent frame being biased in itsexpanded configuration and being collapsible to a compressed deliveryarrangement for loading within delivery system 100. The stent frame isconstructed to self-deploy or self-expand when released from deliverysystem 100. In an embodiment, a prosthetic heart valve useful withembodiments hereof can be a prosthetic heart valve as disclosed in U.S.Pat. Appl. Pub. No. 2008/0071361 to Tuval et al., which is incorporatedby reference herein in its entirety. Other non-limiting examples oftranscatheter heart valve prostheses useful with systems and methods ofthe present disclosure are described in U.S. Pat. Appl. Pub. No.2006/0265056 to Nguyen et al., U.S. Pat. Appl. Pub. No. 2007/0239266 toBirdsall, and U.S. Pat. Appl. Pub. No. 2007/0239269 to Dolan et al.,each of which is incorporated by reference herein in its entirety.

As shown in FIG. 1, in accordance with techniques known in the field ofinterventional cardiology and/or interventional radiology, deliverysystem 100 is transluminally advanced in a retrograde approach throughthe vasculature to the treatment site, which in this instance is atarget diseased native aortic valve AV that extends between a patient'sleft ventricle LV and a patient's aorta A. Delivery of delivery system100 to the native aortic valve AV is accomplished via a percutaneoustransfemoral approach in which the delivery system is tracked throughthe femoral artery, up the aorta and around the aortic arch in order toaccess the native aortic valve AV. Delivery system 100 may also bepositioned within the desired area of the heart via different deliverymethods known in the art for accessing heart valves. During delivery,the prosthetic heart valve remains compressed within distal capsulesection 102 of the delivery system. Delivery system 100 is advanceduntil distal tip 104 is distal to the native aortic valve AV anddisposed within the left ventricle LV as shown in FIG. 1. As deliverysystem 100 is tracked to the native aortic valve AV, the delivery systemmay abut against or hug the vessel wall as shown in FIG. 1, therebyresulting in a non-centered position in the aorta A and in the nativeaortic valve AV. As described in the background section hereof, properpositioning of the delivery system and prosthetic heart valve isrequired in order to successfully implant the prosthetic heart valveagainst the native annulus. If the prosthesis is incorrectly positionedrelative to the native annulus, the deployed device can leak anddislodge from the native valve implantation site.

Embodiments hereof are directed to a delivery system for a transcathetervalve prosthesis, the delivery system having an integral centeringmechanism for positioning the valve prosthesis in situ such that boththe delivery system and the valve prosthesis are circumferentiallycentered in a vessel at the target implantation site, such as forexample an aorta A and a native aortic valve AV. As used herein,“circumferentially centered” and/or “circumferentially center” include adelivery system having a distal portion thereof that is placed orsituated in the center of a body lumen such that a centerpoint of thedistal portion of the delivery system is equidistant to the vessel wallof the body lumen within a tolerance of 10% of the mean lumen diameterof the body lumen. As used herein, “lumen diameter” for a circular bodylumen is the diameter of the circular lumen, “lumen diameter” for aneccentric or non-circular body lumen is the diameter of a circular lumenwith an equivalent perimeter length, and “lumen diameter” for an ovalbody lumen is the average of the major and minor diameters of the ovallumen. The integral centering mechanisms described herein prevent thedelivery system from abutting against or hugging the vessel wall aroundcurvatures thereof as described above with respect to FIG. 1. As such,the integral centering mechanisms described herein allow a deliverysystem to self-center itself without the requirement that the user steerthe delivery system to the center of the body lumen. In addition, theintegral centering mechanisms described herein may be utilized at anytime during the delivery process. For example, although described hereinprimarily with respect to circumferentially centering the deliverysystem and valve prosthesis after the distal portion of the deliverysystem is positioned at the target native valve site but prior todeployment of the valve prosthesis, the integral centering mechanismsdescribed herein may be utilized before the distal portion of thedelivery system is positioned at the target native valve site to push ordeflect the delivery system off a vessel wall while the delivery systemis being tracked to the target native valve site.

With reference to FIG. 2, a delivery system 200 is configured forendoluminal transcatheter repair/replacement of a defective heart valveand includes two, longitudinally spaced apart integral centeringmechanisms 216. In FIG. 2, delivery system 200 is depicted in situ, withcentering mechanism 216 in a deployed or expanded configuration and aprosthetic heart valve (not shown) in a delivery or compressedconfiguration in which the prosthetic heart valve is loaded within adistal capsule section 202 of the delivery system. Although deliverysystem 200 is shown with two centering mechanisms 216 at longitudinallyspaced-apart locations, delivery system 200 may include only onecentering mechanism or may include more than two centering mechanisms atlongitudinally spaced-apart locations along delivery system 200.Centering mechanisms 216 are positioned proximal to distal capsulesection 202, and are positioned to deploy within the aorta A in order tocenter delivery system 200 and the prosthetic heart valve containedtherein in the aorta A and in the native aortic valve AV.

Similar to delivery system 100, as best shown on FIG. 3A, deliverysystem 200 includes a tubular outer shaft 206 defining a lumen 208there-through and a tubular inner shaft 210 defining a lumen 212there-through. A distal tip 204 (see FIG. 2) is coupled to a distal endof inner shaft 210. Inner shaft 210 is concentrically disposed withinlumen 208 of outer shaft 206, and lumen 212 of inner shaft 210 may besized to slidingly receive a guidewire 214 such that delivery system 200may be tracked over the guidewire during delivery of the prostheticheart valve.

Each centering mechanism 216 includes at least two expandable arms orwings 218A, 218B that, when expanded or deployed, are configured todeflect off of the vessel wall, i.e., aorta A, in order to push deliverysystem 200 away from the walls of the vessel and circumferentiallycenter the delivery system within the vessel for a more successfulprosthetic valve deployment. Each wing 218A, 218B is an individual orseparate flat or ribbon-like element that is formed from aself-expanding material and shape-set in the deployed or expandedconfiguration shown in FIG. 2. In centering mechanism 216 is in theexpanded or deployed configuration, each wing 218A, 218B is curved orarched such that each wing bows or bulges radially outward with respectto outer shaft 206. Stated another way, when the centering mechanism isin an expanded configuration, each wing 218A, 218B has a curved, bowedprofile.

During delivery of delivery system 200, each wing 218A, 218B iscollapsed or compressed into a delivery configuration in which each wingis enclosed or housed between outer shaft 206 and inner shaft 210 of thedelivery system. More particularly, FIG. 3 and FIG. 3A illustrate aportion of delivery system 200, with wings 218A, 218B compressed into adelivery configuration. Each wing 218A has a first end 226A that isattached or anchored to inner shaft 210 and a second or opposing end224A that is unattached so that the second end is free to slide overinner shaft 210 for deployment and recapture as will be explained inmore detail herein. Similarly, each wing 218B has a first end 226B thatis attached or anchored to inner shaft 210 and a second or opposing end224B that is unattached so that the second end is free to slide overinner shaft 210 for deployment and recapture. First ends 226A, 226B ofwings 218A, 218B, respectively, are attached to inner shaft 210 viabonding or adhesive. When compressed or collapsed, wings 218A, 218Bextend between outer shaft 206 and inner shaft 210 as best shown in FIG.3A, within lumen 208 of outer shaft 206, and thus advantageously do notincrease the outer diameter or profile of delivery system 200. Outershaft 206 includes openings or windows 220A, 220B formed through asidewall thereof at circumferentially opposing positions. Openings orwindows 220A, 220B are longitudinally aligned with wings 218A, 218B.However, when compressed or collapsed, openings or windows 220A, 220Bcircumferentially offset or not aligned with wings 218A, 218B such thatthe wings are contained within outer shaft 206. Stated another way, whencentering mechanism 216 is in a delivery configuration, wings 218A, 218Bare offset from windows 220A, 220B, respectively, each wing 218A, 218Bhas a straightened profile that is enclosed between the outer and innershafts.

When it is desired to deploy or expand centering mechanisms 216, outershaft 206 is rotated or turned relative to inner shaft 210 as indicatedby directional arrow 222 on FIG. 4 in order to circumferentially alignwindows 220A, 220B with wings 218A, 218B. Once the windows are alignedwith the wings, wings 218A, 218B are exposed and permitted toself-expand. More particularly, unattached or free second ends 224A,224B of wings 218A, 218B, respectively, slide over inner shaft 210 in aproximal direction towards attached or anchored first ends 226A, 226B ofwings 218A, 218B, respectively. Wings 218A, 218B resume their shape-setdeployed or expanded configuration when permitted to radially expandthrough windows 220A, 220B. In the embodiment shown in FIGS. 4 and 4A,outer shaft 206 is rotated approximately 90 degrees in order tocircumferentially align windows 220A, 220B with wings 218A, 218B. Thedegree or amount of rotation that is required may vary according toapplication including rotation angles between 10 and 90 ninety degrees.In addition, although described with second ends 224A, 224B of wings218A, 218B, respectively, being unattached or free to slide in aproximal direction over inner shaft 210, in another embodiment hereof(not shown) first ends 226A, 226B of wings 218A, 218B, respectively, mayalternatively be unattached or free to slide in a distal direction overinner shaft 210 when wings 218A, 218B expand or deploy through windows220A, 220B while the second ends of the wings are attached or anchoredto the inner shaft.

Centering mechanisms 216 need only be deployed if desired by the user.For example, if fluoroscopy reveals that delivery system 200 iscircumferentially centered within the aorta A and in the native aorticvalve AV without deployment of centering mechanisms 216, wings 218A,218B may remain housed or contained within the delivery systemthroughout the delivery process. However, if fluoroscopy reveals thatdelivery system 200 is hugging or clinging to the vessel wall, centeringmechanisms 216 may be selectively deployed in order to deflect or pushdelivery system 200 off the vessel wall. Centering mechanisms 216 arepreferably expanded or deployed prior to deployment of the prostheticheart valve, and centering mechanisms 216 may remain deployed orexpanded during deployment of the prosthetic heart valve or may beretracted or recaptured prior to deployment of the prosthetic heartvalve. In order to retract or recapture wings 218A, 218B, outer shaft206 is rotated in the opposite direction from directional arrow 222 suchthat wings 218A, 218B are no longer circumferentially aligned withwindows 220A, 220B. Unattached or free second ends 224A, 224B of wings218A, 218B, respectively, slide over inner shaft 210 in a distaldirection away from attached or anchored first ends 226A, 226B of wings218A, 218B, respectively, such that wings 218A, 218B collapse and areagain contained or housed within outer shaft 206 in a deliveryconfiguration described above with respect to FIGS. 3 and 3A.

In another embodiment hereof, each centering mechanism may include morethan two opposing wings. For example, in the embodiment of FIG. 5, acentering mechanism having three circumferentially spaced wings 518A,518B, 518C is shown in a delivery configuration in which each wing isenclosed or housed within a lumen 508 between an outer shaft 506 andinner shaft 510 of a delivery system 500. Outer shaft 506 includesopenings or windows 520A, 520B, 520C formed through a sidewall thereofat circumferentially spaced-apart positions that permit self-expansionof wings 518A, 518B, 518C when the windows are circumferentially alignedwith the wings. As described above respect to outer shaft 206, in orderto deploy wings 518A, 518B, 518C, outer shaft 506 is rotated or turnedin order to circumferentially align windows 520A, 520B, 520C and wings518A, 518B, 518C.

In another embodiment hereof, rather than deploying the centeringmechanism via rotation of the outer shaft, the outer shaft may betranslated in order to align the windows and the wings. Moreparticularly, a portion of a delivery system 600 having a centeringmechanism 616 is shown in FIG. 6 with wings 618A, 618B collapsed orcompressed into a delivery configuration and in FIG. 7 with wings 618A,618B in a deployed or expanded configuration. Outer shaft 606 includesopenings or windows 620A, 620B formed through a sidewall thereof atcircumferentially opposing positions. Openings or windows 620A, 620B arecircumferentially aligned with wings 218A, 218B. However, whencompressed or collapsed as shown in FIG. 6, openings or windows 620A,620B are longitudinally offset or not aligned with wings 618A, 618B suchthat the wings are contained within outer shaft 606. When it is desiredto deploy or expand centering mechanism 616, outer shaft 606 isproximally retracted as indicated by directional arrow 622 on FIG. 7 inorder to longitudinally align windows 620A, 620B with wings 618A, 618B.Once the windows are aligned with the wings, wings 618A, 618B areexposed and permitted to self-expand similar to wings 218A, 218Bdescribed above.

In another embodiment hereof, the wings may be formed via elongated flator ribbon-like elements. More particularly, with reference to FIG. 8, aflat or ribbon-like elongated element 828 is shown removed from adelivery system for sake of illustration only. Elongated element 828 isformed from a self-expanding material and shape-set in the deployed orexpanded configuration shown in FIG. 8. Elongated element 828 has aproximal portion 830 and a distal portion 831 that includes twoconsecutive or sequential wings 818A. When disposed in a delivery system(not shown), at least two elongated elements would be housed between theouter and inner shafts of the delivery system at circumferentiallyopposing locations. A second or distal end 824A of each elongatedelement 828 is unattached or free to slide over the inner shaft of thedelivery system, while a first or proximal end 826A is attached oranchored to the inner shaft. When it is desired to deploy or expandsequential wings 818A, the outer shaft (not shown) of the deliverysystem is longitudinally translated as described above with respect tothe embodiment of FIGS. 6-7 or is rotated as described above withrespect to the embodiment of FIGS. 4-5 in order to align sequentialwings 818A with two sequential openings or windows (not shown) of theouter shaft of the delivery system. Once the windows are aligned withthe wings, sequential wings 818A are exposed and permitted toself-expand similar to wings 218A, 218B and/or wings 618A, 618Bdescribed above. More particularly, unattached or free second end 824Aof each elongated element 828 slides over the inner shaft in a proximaldirection towards attached or anchored first end 826A. Sequential wings818A resume their shape-set deployed or expanded configuration whenpermitted to radially expand through the aligned windows.

In another embodiment hereof, flat or ribbon-like elongated element 828is not required to be formed from a self-expanding material andshape-set in the deployed or expanded configuration. Rather, a first orproximal end 826A of elongated element 828 is unattached or free toslide over the inner shaft (not shown) of the delivery system, while asecond or distal end 824A is attached or anchored to the inner shaft.First or proximal end 826A is distally advanced by a user with a pushrod (not shown) such that portions of element 828 are pushed or extendedthrough two sequential openings or windows (not shown) of the outershaft of the delivery system, thereby forming deployed sequential wings818A. In this embodiment, the amount or degree of radial expansion maybe controlled by the user. More particularly, the user may selectivelyincrease the amount or degree of radial expansion, or height of wings818A, by further distally advancing the push rod and thereby furtherpushing elongated element 828 to cause an additional amount or length ofelongated element 828 to be pushed or extended through the twosequential openings or windows of the outer shaft. In another embodimenthereof (not shown), radial expansion or deployment of the wings maycollectively operate similar to a Chinese finger cuff or finger trap. Ina first state or configuration, the wings collectively have a relativelyslim or narrow profile and in a second state or configuration, the wingscollectively have a relatively thick or wide profile that contacts thevessel wall in order to wedge or center the delivery system within thevessel. When stability or centering is desired, opposing ends of eachwing are pushed together in order to transform the wings into the secondstate or configuration in which the wings collectively have a relativelythick or wide profile that contacts the vessel wall.

In any embodiment hereof, the inner shaft may include grooves or tracksto assist in sliding and deployment of the wings. For example, FIGS. 9and 9A illustrates an exemplary inner shaft 910 removed from a deliverysystem for illustration purposes only. Inner shaft 910 defines a lumen912 for receiving a guidewire 914 there-through. Inner shaft 910includes a longitudinal groove 932 formed on an outside surface thereoffor receiving wings such as but not limited to wings 218A/218B, wings618A/618B, and/or elongated element 828 having wings 818A formedthereon. Groove 932 serves as a track or pathway for the wing when it issliding during deployment thereof.

FIG. 10 illustrates another embodiment hereof in which the wings of thecentering mechanism have a different deployed configuration. In FIG. 10,a delivery system 1000 is depicted in situ, with centering mechanisms1016 in a deployed or expanded configuration and a prosthetic heartvalve (not shown) in a delivery or compressed configuration in which theprosthetic heart valve is loaded within a distal capsule section 1002 ofthe delivery system. In this embodiment, delivery system 1000 is shownwith three centering mechanisms 1016 at longitudinally spaced-apartlocations. A first centering mechanism 1016 is positioned proximal todistal capsule section 1002, a second centering mechanism 1016 ispositioned to deploy within the aorta A distal to the branches of theaortic arch, and a third centering mechanism 1016 is positioned todeploy within the aorta A proximal to the branches of the aortic arch.Similar to centering mechanisms 216, each centering mechanism 1016includes at least two expandable arms or wings 1018A, 1018B that, whenexpanded or deployed, are configured to deflect off of the vessel wall,i.e., aorta A, in order to push delivery system 1000 away from the wallsof the vessel and center the delivery system within the vessel for amore successful prosthetic valve deployment. Each wing 1018A, 1018B isan individual or separate flat or ribbon-like element that is formedfrom a self-expanding material and shape-set in the deployed or expandedconfiguration shown in FIG. 10. In this embodiment the deployedconfiguration of wings 1018A, 1018B differs from the deployedconfiguration of wings 218A, 218B because wings 1018A, 1018B are eachconfigured to extend circumferentially or transversely around theperimeter of outer shaft 1006 rather than extend longitudinally alongthe outer shaft. Although not shown in the view of FIG. 10, the openingsor windows formed through outer shaft 1006 similar extendcircumferentially around the perimeter of the outer shaft and outershaft 1006 may be rotated (similar to outer shaft 206) or translated(similar to outer shaft 606) in order to align the windows with wings1018A, 1018B.

FIG. 11 illustrates another embodiment hereof in which the centeringmechanisms have a different deployed configuration. In FIG. 11, adelivery system 1100 is depicted in situ, with centering mechanisms 1116in a deployed or expanded configuration and a prosthetic heart valve(not shown) in a delivery or compressed configuration in which theprosthetic heart valve is loaded within a distal capsule section 1102 ofthe delivery system. In this embodiment, delivery system 1100 is shownwith two centering mechanisms 1116 at longitudinally spaced-apartlocations with a first centering mechanism 1116 is positioned distal todistal capsule section 1102 and a second centering mechanism 1116 ispositioned to deploy within the aorta A distal to the branches of theaortic arch. However, delivery system 1100 may be modified to includefewer centering mechanisms or additional centering mechanisms and thelongitudinal position of the centering mechanisms may vary according toapplication. In this embodiment, each centering mechanism 1116 includesa coiled wing 1134 that, when expanded or deployed, is configured todeflect off of the vessel wall, i.e., aorta A, in order to push deliverysystem 1100 away from the walls of the vessel and center the deliverysystem within the vessel for a more successful prosthetic valvedeployment. Each coiled wing 1134 is an individual or separate flat orribbon-like element that is formed from a self-expanding material andshape-set in the deployed or expanded configuration shown best in FIG.14. The flat or ribbon-like element that forms coiled wing 1134distributes deployment forces onto the vessel wall.

During delivery of delivery system 1100, each coiled wing 1134 iscompressed into a delivery configuration in which the coiled wing isenclosed or housed between an outer shaft 1106 and an inner shaft 1110of the delivery system, within lumen 1108 of outer shaft 1106 shown inFIG. 12. Inner shaft 1110 is rotatable relative to outer shaft 1106.More particularly, FIG. 12 illustrates a portion of delivery system 1100wherein only a second or free end 1136 of the coiled wing extendsthrough an opening or window 1120 formed in outer shaft 1106 and theremaining length of the coiled wing is wrapped around inner shaft 1110and housed within lumen 1108 of the delivery system. In addition, FIG.13 illustrates coiled wing 1134 in its compressed or deliveryconfiguration and removed from the delivery system for sake ofillustration only. When each centering mechanism 1116 in its compressedor delivery configuration, each coiled wing 1134 winds in a series ofone or more loops around an outer surface of inner shaft 1110 in ahelical or corkscrew fashion and consecutive or adjacent loops thereofare stacked against and contacting each other with substantially nospace therebetween. Stated another way, when the centering mechanismsare in a delivery configuration, each wing 1134 has a series of windingsthat extend around inner shaft 1110 such that each winding is enclosedbetween the outer and inner shafts. Each coiled wing 1134 has a firstend 1138 that is attached or anchored to inner shaft 1110 and second oropposing end 1136 that is unattached so that the second end is free toextend through window 1120 for deployment and recapture as will beexplained in more detail herein. First end 1138 of coiled wing 1134 isattached to inner shaft 1110 via bonding or adhesive. Window 1120 isformed through a sidewall of outer shaft 1106 and is circumferentiallyand longitudinally aligned with second or free end 1136 of coiled wing1134.

When it is desired to deploy or expand centering mechanisms 1116, innershaft 1110 is rotated or turned relative to outer shaft 1106 asindicated by directional arrow 1122 on FIG. 14. More particularly, asinner shaft 1110 is rotated, second or free end 1136 of coiled wing 1134extends through window 1120 and coiled wing 1134 begins to wrap or windaround the perimeter of outer shaft 1106. In an embodiment, second orfree end 1136 of coiled wing 1134 is slightly rounded at the edgesthereof in order to be atraumatic and extends through window 1120 atapproximately a 45 degree angle relative to window 1120. Inner shaft1110 is rotated until the entire length of coiled wing 1134 extendsthrough window 1120 as shown in FIG. 14, and coiled wing 1134 ispermitted to self-expand to its shape-set deployed or expandedconfiguration. FIG. 15 illustrates coiled wing 1134 in its deployed orexpanded configuration and removed from the delivery system for sake ofillustration only. When each centering mechanism 1116 is in its deployedor expanded configuration, each coiled wing 1134 winds in a series ofone or more loops or windings around an outer surface of outer shaft1106 in a helical or corkscrew fashion and consecutive or adjacent loopsthereof are spaced apart from each other and not contacting each other.Stated another way, coiled wing 1134 is deployed around and encirclesouter shaft 1106 and consecutive or adjacent loops thereof haveincrementally decreasing diameters such that gaps or spaces extendbetween the adjacent loops in order to allow blood to flow therebetween.

As shown in FIG. 14, the windings of coiled wing 1134 extend in a singleplane that is transverse to delivery system 1100. In order to retract orrecapture coiled wing 1134, inner shaft 1110 is rotated in the oppositedirection from directional arrow 1122. Coiled wing 1134 is pulled backinto lumen 1108 of outer shaft 1106 and winds or wraps around innershaft 1110 in the delivery configuration described above with respect toFIGS. 12 and 13.

In another embodiment shown in FIG. 12A and FIG. 14A, the windings of acoiled wing 1134A longitudinally extend to form a conical profile. FIG.12A illustrates a portion of a delivery system wherein only a second orfree end 1136A of the coiled wing extends through an opening or window1120A formed in outer shaft 1106A and the remaining length of the coiledwing is wrapped around inner shaft 1110A. Deployment of coiled wing1134A is similar to deployment of coiled wing 1134 except that innershaft 1110A moves distally as indicated by directional arrow 1123A as itis being rotated in order to allow coiled wing 1134A to deploy out ofwindow 1120A. More particularly, when it is desired to deploy or expandcoiled wing 1134A, inner shaft 1110A is rotated or turned relative toouter shaft 1106A as indicated by directional arrow 1122A on FIG. 12A.As inner shaft 1110A is rotated and moves distally, second or free end1136A of coiled wing 1134A extends through window 1120A and coiled wing1134A forms a conical coil around the perimeter of outer shaft 1106A assecond or free end 1136A progresses or moves distally relative to outershaft 1106A. Inner shaft 1110A is rotated until the entire length ofcoiled wing 1134A extends through window 1120A as shown in FIG. 14A, andcoiled wing 1134A is permitted to self-expand to its shape-set deployedor expanded configuration.

FIGS. 16 and 16A illustrates another embodiment hereof in which thecentering mechanism includes self-expanding multiple filaments that maybe selectively deployed at or adjacent to the native valve annulus. InFIG. 16, a delivery system 1600 is depicted in situ, with centeringmechanism 1616 in a deployed or expanded configuration and a prostheticheart valve (not shown) in a delivery or compressed configuration inwhich the prosthetic heart valve is loaded within a distal capsulesection 1602 of the delivery system. In this embodiment, centeringmechanism 1616 includes a plurality of self-expanding elongatedfilaments 1642A, 1642B, 1642C, 1642D, 1642E, 1642F, 1642G, 1642H(collectively referred to herein as elongated filaments 1642) that, whenexpanded or deployed, are configured to deflect off of the native valveanatomy in order center distal capsule portion 1602 of the deliverysystem within the native valve annulus for a more successful prostheticvalve deployment. Although centering mechanism 1616 is shown with eightfilaments circumferentially spaced apart, centering mechanism 1616 mayinclude a greater number of filaments or a fewer number of filaments,depending upon application. Each elongated filament 1642 is anindividual or separate strand having at least a distal portion thereofformed from a self-expanding material and shape-set in the deployed orexpanded configuration shown in FIG. 16.

In this embodiment, in addition to an outer shaft 1606 that defines alumen 1608 and an inner shaft 1110 that defines a central lumen 1612 forreceiving a guidewire 1614, delivery system 1600 includes an additionaloutermost shaft 1640. Outer shaft 1606 is positioned within a lumen 1646defined by outermost shaft 1640. Outermost shaft 1640 is shorter thanouter shaft 1606, with a distal end 1641 positioned proximal to aproximal end of distal capsule portion 1602. In an embodiment hereof,distal end 1641 is positioned between 6-8 cm from a distal end 1604 ofdelivery system 1600. Outermost shaft 1640 includes a plurality oflumens 1644A, 1644B, 1644C, 1644D, 1644E, 1644F, 1644G, 1644H(collectively referred to herein as lumens 1644) formed in a sidewallthereof for housing or receiving elongated filaments 1642A, 1642B,1642C, 1642D, 1642E, 1642F, 1642G, 1642H, respectively. Althoughoutermost shaft 1640 is shown with eight lumens circumferentially spacedapart, it will be understood by one of ordinary skill in the art thatthe number of lumens corresponds to the number of filaments utilizedtherein, which may vary according to application as described above.Elongated filaments 1642 are slidingly positioned within lumens 1644,and elongated filaments 1642 may be moved relative to outermost shaft1640 in order to selectively deploy or expand elongated filaments 1642.

During delivery of delivery system 1600, each elongated filament 1642 iscompressed into a delivery configuration in which the entire length ofeach filament is housed within its respective lumen 1644 of outermostshaft 1640. When in its compressed or delivery configuration, the distalportion of each elongated filament 1642 has a straightened profile thatis enclosed within one of lumens 1644 formed in the sidewall ofoutermost shaft 1640. When it is desired to deploy or expand centeringmechanism 1616, elongated filaments 1642 are distally advanced by theuser such that the distal portions thereof are exposed or extend out ofoutermost shaft 1640 and the distal portion of each elongated filament1642 is permitted to self-expand to their shape-set deployed or expandedconfiguration in which the distal portion of each elongated filament hasa curved, bowed profile. Elongated filaments 1642 may be simultaneouslydeployed at the same time, or may be individually deployed as needed.Outermost shaft 1640 and elongated filaments 1642 housed therein do notmove when distal capsule portion 1602 is retracted in order to deploythe prosthetic heart valve, thus ensuring that delivery system 1600remains circumferentially centered within the native anatomy duringdeployment of the prosthetic heart valve. After the prosthetic heartvalve is deployed as desired, in order to retract or recapture centeringmechanism 1616, elongated filaments 1642 are proximally retracted by theuser such that the distal portions thereof are pulled back into theirrespective lumen 1644 of outermost shaft 1640.

FIG. 17 illustrates another embodiment hereof in which, similar to theembodiment of FIG. 16, the centering mechanism includes multiplefilaments that may be selectively deployed at or adjacent to the nativevalve annulus. However, in the embodiment of FIG. 17, rather than beingshape-set or formed from a self-expanding material, the distal ends ofthe filaments are fixed so that distal advancement of the filamentsresults in the distal portions thereof bulging radially outward as shownin FIG. 17. More particularly, in FIG. 17, a delivery system 1700 isdepicted in situ, with centering mechanism 1716 in a deployed orexpanded configuration and a prosthetic heart valve (not shown) in adelivery or compressed configuration in which the prosthetic heart valveis loaded within a distal capsule section 1702 of the delivery system.Similar to centering mechanism 1616, centering mechanism 1716 includes aplurality of elongated filaments although only elongated filaments1742A, 1742B are visible in the side view of FIG. 17. Each elongatedfilament 1742 is an individual or separate strand that, when the distalportion thereof is expanded or deployed, are configured to deflect offof the native valve anatomy in order center distal capsule portion 1702of the delivery system within the native valve annulus for a moresuccessful prosthetic valve deployment. Distal end 1748 of eachelongated filament 1742 is attached or fixed to an outer surface ofdistal capsule portion 1702. Delivery system 1700 includes an additionaloutermost shaft 1740 which is similar to outermost shaft 1640 describedabove and includes a plurality of lumens (not shown in FIG. 17) formedin a sidewall thereof for receiving elongated filaments 1742. Elongatedfilaments 1742 are slidingly positioned within the lumens of outermostshaft 1740, and elongated filaments 1742 may be moved relative tooutermost shaft 1740 in order to selectively deploy or expand elongatedfilaments 1742 as will be described in more detail herein. A distal end1741 is positioned proximal to a proximal end of distal capsule portion1702.

During delivery of delivery system 1700, each elongated filament 1742 ishoused within its respective lumen of outermost shaft 1740 with a distalportion of each elongated filament 1742 extending over an outer surfaceof distal capsule portion 1702. During delivery, distal portions ofelongated filaments 1742 have a straightened profile that is flushagainst the outer surface of distal capsule portion 1702. When it isdesired to deploy or expand centering mechanism 1716, the proximal endsof elongated filaments 1742 are distally advanced by the user such thatthe distal portions thereof bow or bulge radially outwards as shown inFIG. 17. When each elongated filament 1742 is in an expandedconfiguration, the distal portion thereof has a curved, bowed profileradially spaced apart from the outer surface of distal capsule portion1702. With distal ends 1748 thereof attached to distal capsule portion1702, elongated filaments 1742 move proximally with distal capsuleportion 1702 when the distal capsule portion is retracted in order todeploy the prosthetic heart valve. After the prosthetic heart valve isdeployed as desired, in order to retract or recapture centeringmechanism 1716, the proximal ends of elongated filaments 1742 areproximally retracted by the user such that the bulged or bowed distalportions thereof are straightened back into their delivery configurationin which the distal portions of elongated filaments 1742 are flush withthe outer surface of distal capsule portion 1702.

The longitudinal position of centering mechanism 1716 may vary accordingto application. For example, in another embodiment hereof (not shown),the distal end 1748 of each elongated filament 1742 may be attached orfixed to an outer surface of the outer shaft (not shown) rather than todistal capsule portion 1702. The distal portions of the filaments arethus positioned to be deployed within ascending aorta and/or aortic archin order center distal capsule portion 1702 of the delivery systemwithin the native valve annulus for a more successful prosthetic valvedeployment. In this embodiment, the outer shaft and deployed distal endsof each elongated filament do not move when distal capsule portion 1702is retracted in order to deploy the prosthetic heart valve, thusensuring that delivery system 1700 remains circumferentially centeredwithin the native anatomy during deployment of the prosthetic heartvalve.

FIGS. 18 and 19 illustrate another embodiment hereof in which, similarto the embodiment of FIG. 16, the centering mechanism includes multipleself-expanding filaments that may be selectively deployed. However, inthe embodiment of FIG. 18, rather than being deployed at or adjacent tothe native valve annulus, the filaments include soft or flexible endsthat are deployed within the aorta A distal to the branches of theaortic arch to deflect off of the vessel wall, i.e., aorta A, in orderto push delivery system 1800 away from the walls of the vessel andcenter the delivery system within the vessel for a more successfulprosthetic valve deployment. More particularly, in FIG. 18, a deliverysystem 1800 is depicted in situ, with centering mechanism 1816 in adeployed or expanded configuration and a prosthetic heart valve (notshown) in a delivery or compressed configuration in which the prostheticheart valve is loaded within a distal capsule section 1802 of thedelivery system. Delivery system 1800 includes an additional outermostshaft 1840 which is similar to outermost shaft 1840 described above andincludes a plurality of lumens (not shown in FIG. 18) for receiving aplurality of filaments 1842. Outermost shaft 1840 extends over an outershaft 1806. Filaments 1842 are slidingly positioned within the lumens ofoutermost shaft 1840, and filaments 1842 may be moved relative tooutermost shaft 1840 in order to selectively deploy or expand filaments1842 as will be described in more detail herein. A distal end 1841 ofoutermost shaft 1840 is positioned proximal to a proximal end of distalcapsule portion 1802.

Similar to centering mechanism 1616, centering mechanism 1816 includes aplurality of self-expanding filaments although only filaments 1842A,1842B are visible in the side view of FIG. 18. Each filament 1842 is anindividual or separate elongated strand having a relatively softer andmore flexible distal portion 1850 relative to the length proximalthereto. For example, suitable materials for distal portion 1850 includeflexible polymeric materials such as polyethylene or polypropylene,while the remaining length of filament 1842 may be formed from orreinforced with Nitinol or stainless steel for increased strength andpushability. Distal portion 1850 of each filament 1842 is self-expandingand pre-formed such that the distal portion curls radially outward andlongitudinally in a proximal direction when extended from distal end1841 of outermost shaft 1840. More particularly, as shown in FIG. 18,when deployed distal portion 1850 of each filament 1842 radially expandsto contact the vessel wall and a distal end 1852 of each filament 1842curls underneath itself to contact an outer surface of outermost sheath1840. Distal end 1852 may be covered with soft material such as siliconeor rubber to prevent atraumatic damage to the vessel wall as it isadvancing. The curled deployed configurations of distal portions 1850 offilaments 1842 apply a spring force against the vessel wall and providestability by expanding between the vessel wall and the outer surface ofoutermost sheath 1840.

During delivery of delivery system 1800, each filament 1842 iscompressed into a delivery configuration in which the entire length ofeach filament is housed within its respective lumen of outermost shaft1840. When in its compressed or delivery configuration, each filament1842 is straightened. As best shown in FIG. 19, during delivery ofcatheter 1800, distal end 1841 of outermost shaft 1850 abuts against aproximal end of distal capsule portion 1802. In an embodiment hereof,distal end 1841 may be funnel-shaped or flared in order to mate with theproximal end of distal capsule portion 1802. Such a flared configurationensures that distal end 1841 is flush against the proximal end of distalcapsule portion 1802 such that there is no leading edge during delivery.In addition, the flared configuration of distal end 1841 of outermostshaft 1840 aids in deployment of filaments 1842 because the funnel-shapeor flare directs or guides distal ends 1852 of the filaments radiallyoutward during deployment thereof.

When it is desired to deploy or expand centering mechanism 1816,outermost shaft 1840 is proximally retracted such that distal end 1841thereof is spaced apart from distal capsule portion 1802 as shown inFIG. 18. By distancing outermost shaft 1840 from distal capsule 1802,filaments 1842 have sufficient space to be extended from outermost shaft1840 and distal capsule portion 1802 has sufficient space to beproximally retracted during deployment of the prosthetic heart valve.Filaments 1842 are then distally advanced by the user such that distalportions 1850 thereof are exposed or extend out of outermost shaft 1840and distal portions 1850 of filaments 1842 are permitted to self-expandto their shape-set deployed or expanded configuration shown in FIG. 18.Filaments 1842 may be simultaneously deployed at the same time, or maybe individually deployed as needed in order to correct alignment ofdelivery system 1800. Outermost shaft 1840 and filaments 1842 housedtherein do not move when distal capsule portion 1802 is retracted inorder to deploy the prosthetic heart valve, thus ensuring that deliverysystem 1800 remains circumferentially centered within the native anatomyduring deployment of the prosthetic heart valve. After the prostheticheart valve is deployed as desired, in order to retract or recapturecentering mechanism 1816, filaments 1842 are proximally retracted by theuser such that the distal portions thereof are pulled back into theirrespective lumen of outermost shaft 1840.

FIG. 20 illustrates another embodiment hereof in which the outer shaftof the delivery system may be pre-formed or pre-shaped to include aplurality of deflection segments 2054A, 2054B, 2054C. In FIG. 20, adelivery system 2000 is depicted in situ, with deflection segments2054A, 2054B, 2054C in a deployed or expanded configuration and aprosthetic heart valve (not shown) in a delivery or compressedconfiguration in which the prosthetic heart valve is loaded within adistal capsule section 2002 of the delivery system. In this embodiment,outer shaft 2006 includes a plurality of deflection segments 2054A,2054B, 2054C that are pre-shaped or pre-formed to deflect off of thenative valve anatomy in order center distal capsule portion 2002 of thedelivery system within the native valve annulus for a more successfulprosthetic valve deployment. In this embodiment, delivery system 2000 isshown with three deflection segments at longitudinally spaced-apartlocations. A first deflection segment 2054C is positioned proximal todistal capsule section 2002, a second deflection segment 2054B ispositioned to deploy within the aorta A distal to the branches of theaortic arch, and a third deflection segment 2054A is positioned todeploy within the aorta A proximal to the branches of the aortic arch.However, delivery system 2000 may include only one or two deflectionsegments along a length thereof or may include more than threedeflection segments at longitudinally spaced-apart locations alongdelivery system 2000. Each deflection segment 2054A, 2054B, 2054C iscurved or arched such that it bows or bulges radially outward withrespect to the remaining length of outer shaft 2006. Stated another way,each deflection segment 2054A, 2054B, 2054C has a curved, bowed profilewith respect to the remaining length of outer shaft 2006. In theembodiment of FIG. 20, the deflection segments extend in the same plane,i.e., are co-planar, with respect to the remaining length of outer shaft2006. In another embodiment hereof shown in FIG. 20A, one or moredeflection segments 2054 extend in a different plane with respect to theremaining length of outer shaft 2006 such that deflection segments 2054form a portion of a spiral or corkscrew.

During delivery of delivery system 2000, outer shaft 2006 issufficiently flexible to deform into a substantially straightconfiguration in order to be percutaneously introduced into thevasculature. Once within the aorta, deflection segments 2054A, 2054B,2054C of outer shaft 2006 are permitted to self-expand to theirshape-set deployed or expanded configuration shown in FIG. 20. Since theabdominal aorta has a larger diameter than the aortic arch, deflectionsegments 2054A, 2054B, 2054C of outer shaft 2006 may be tracked throughthe abdominal aorta and into the aortic arch, whereby they contact thetarget vessel wall, i.e., aorta A, and deflect off of the vessel wall,i.e., aorta A, in order to push delivery system 2000 away from the wallsof the vessel and center the delivery system within the vessel for amore successful prosthetic valve deployment.

FIGS. 21 and 22 illustrate another embodiment hereof in which acentering mechanism 2116 includes a lever arm that may be selectivelydeployed within the aorta A to deflect off of the vessel wall, i.e.,aorta A, in order to push the delivery system away from the walls of thevessel and center the delivery system within the vessel for a moresuccessful prosthetic valve deployment. The lever arm is coupled to adistal portion of a kicker tool that may be utilized separately orindependently from the delivery system, or in another embodiment hereof(not shown), the kicker tool may be built into or onto the deliverysystem such that the kicker tool and delivery system are an integratedsystem. More particularly, FIG. 21 illustrates a side view of a kickertool 2160 having a deployable lever arm 2170 while FIG. 22 illustrateskicker tool 2160 being utilized with a delivery system 2100. In FIG. 22,kicker tool 2160 and delivery system 2100 are depicted in situ, withlever arm 2170 in a deployed or expanded configuration and a prostheticheart valve (not shown) in a delivery or compressed configuration inwhich the prosthetic heart valve is loaded within a distal capsulesection 2102 of the delivery system. As shown in FIG. 22, kicker tool2160 is distally advanced over outer shaft 2106 of delivery system 2100until a distal end 2168 of the kicker tool is located proximal to aproximal end of distal capsule section 2102 of the delivery system.

Turning to FIG. 21 and FIG. 21A, kicker tool 2160 in its deliveryconfiguration will be described in more detail. Kicker tool 2160includes a shaft or tubular component 2164 that defines a lumen 2166there-through. Shaft component 2164 includes a window 2165 formedthrough a sidewall thereof such that window 2165 is in fluidcommunication with lumen 2166. Window 2165 is positioned just proximalto lever arm 2170. A handle 2162 having a trigger 2163 is coupled to aproximal end of shaft component 2164, and lever arm 2170 is coupled toan exterior or outer surface of a distal portion of shaft component2164. In this embodiment, lever arm 2170 is an individual or separateflat or ribbon-like element having a first or proximal end 2173 and asecond or distal end 2175. In another embodiment hereof (not shown), thekicker tool may include a plurality of lever arms configured to deflectoff of the vessel wall. First or proximal end 2173 is fixed or attachedto the exterior or outer surface of shaft component 2164, while secondor distal end 2175 is free or unattached to shaft component 2164. Secondor distal end 2175 of lever arm 2170 is slightly rounded at the edgesthereof in order to be atraumatic when deployed against the vessel wall.Lever arm 2170 includes a cut-out portion 2169 forming an integral tab2172, and a distal end of a pull wire 2174 is coupled to an inner orinterior surface of tab 2172. Pull wire 2174 is an elongated elementthat passes through window 2165 of shaft component 2164 and runs orextends within lumen 2166 of shaft component 2164 such that a proximalend thereof is attached to trigger 2163. Stated another way, pull wire2174 passes through window 2165 of shaft component 2164 such that onlydistal portion is positioned exterior to shaft component 2164 and theremaining length of the pull wire is positioned within shaft component2164. During delivery of kicker tool 2160, lever arm 2170 is in adelivery configuration in which lever arm 2170 including tab 2172 isstraight and extends adjacent to or abuts against an outer surface ofshaft component 2164 as shown in the top view of FIG. 21A. Statedanother way, when lever arm 2170 is in a delivery configuration, thelever arm has a straightened profile that is flush against the outersurface of shaft component 2164.

When it is desired to deploy or expand lever arm 2170, kicker tool 2160is oriented or rotated around outer shaft 2106 in order to properlyorient lever arm 2170 with respect to the target deployment site. Oncepositioned as desired, trigger 2163 of handle 2162 is operated by theuser in order to pull or retract on pull wire 2174. With the distal endof pull wire 2174 attached or fixed to the inner surface of tab 2172 oflever arm 2170, tab 2172 bows or curves radially outward since proximalend 2173 of lever arm 2170 is also constrained or fixed to shaftcomponent 2164. Second or distal end 2175 of lever arm 2170 is deflectedor pushed radially outward to its deployed configuration as shown inFIG. 22 and FIG. 22A. More particularly, while proximal end 2173 oflever arm 2170 remains attached to the outer surface of shaft component2164, distal end 2175 of lever arm 2170 expands or flares radially awayfrom the outer surface of shaft component 2164 such that lever arm 2170forms an acute angle between 0 and 90 degrees with respect to the outersurface of shaft component 2164. In the deployed or expandedconfiguration, lever arm 2170 has a curved configuration to apply aspring force against the vessel wall. Kicker tool 2160 and deployedlever arm 2170 do not move when distal capsule portion 2102 is retractedin order to deploy the prosthetic heart valve, thus ensuring thatdelivery system 2100 remains circumferentially centered within thenative anatomy during deployment of the prosthetic heart valve. Afterthe prosthetic heart valve is deployed as desired, in order to retractor recapture lever arm 2170, trigger 2163 is released in order to removetension on pull wire 2174 and thereby collapse lever arm 2170 and/orpermit the lever arm to return or revert to its delivery configuration.In another embodiment hereof, an outer sleeve or cover (not shown) maybe distally advanced over the deployed lever arm in order to collapseand recapture the lever arm for removal.

In another embodiment hereof as shown in FIG. 21B and FIG. 22B, thekicker tool includes a hinge 2171 in order to deploy a lever arm 2170B.Similar to lever arm 2170, lever arm 2170B is an individual or separateflat or ribbon-like element having a first or proximal end 2173B and asecond or distal end 2175B. First or proximal end 2173B is fixed orattached to the exterior or outer surface of shaft component 2164B,while second or distal end 2175B is free or unattached to shaftcomponent 2164B. Hinge 2171 is positioned on an exterior surface ofshaft component 2164B and extends over proximal end 2173B of lever arm2170B. A distal end of a pull wire 2174B is attached to an exteriorsurface of lever arm 2170B. Similar to pull wire 2174, pull wire 2174Bis an elongated element that passes through window 2165B of shaftcomponent 2164B and runs or extends within the lumen of shaft component2164B such that a proximal end thereof is attached to a trigger (notshown in FIG. 21B and FIG. 22B). During delivery, lever arm 2170B is ina delivery configuration in which the lever arm is straight and extendsadjacent to or abuts against an outer surface of shaft component 2164Bas shown in the top view of FIG. 21B. Stated another way, when lever arm2170B is in a delivery configuration, the lever arm has a straightenedprofile that is flush against the outer surface of shaft component2164B.

When it is desired to deploy or expand lever arm 2170B, the trigger isoperated by the user in order to pull or retract on pull wire 2174B.With the distal end of pull wire 2174B coupled to the exterior surfaceof lever arm 2170B, a second or unattached free end 2175B of lever arm2170B is pulled proximally and radially outward since proximal end 2173Bof lever arm 2170B is constrained or fixed to shaft component 2164B.Lever arm 2170B bends and deforms underneath hinge 2171 to permit secondor distal end 2175B to flare or extend radially outward to its deployedconfiguration as shown in FIG. 22B. More particularly, while proximalend 2173B of lever arm 2170B remains attached to shaft component 2164B,distal end 2175B of lever arm 2170B expands or flares radially away fromthe outer surface of shaft component 2164B such that lever arm 2170Bforms an acute angle with respect to the outer surface of shaftcomponent 2164B. The kicker and deployed lever arm 2170B do not movewhen the prosthetic heart valve is deployed, thus ensuring that thedelivery system remains circumferentially centered within the nativeanatomy during deployment of the prosthetic heart valve. After theprosthetic heart valve is deployed as desired, in order to retract orrecapture lever arm 2170B, the trigger is released in order to removetension on pull wire 2174B. Lever arm 2170B is formed from aself-expanding material such as Nitinol and shape-set in the deliveryconfiguration shown in FIG. 21B. Thus, when tension is removed from pullwire 2174B, lever arm 2170B collapses and/or is permitted to return orrevert to its straightened, delivery configuration. In anotherembodiment hereof, an outer sleeve or cover (not shown) may be distallyadvanced over the deployed lever arm in order to collapse and recapturethe lever arm for removal.

FIGS. 23-28 illustrate another embodiment hereof in which the centeringmechanism includes a plurality of deployable loops that may beselectively deployed at or adjacent to the native valve annulus. In FIG.23, a delivery system 2300 is depicted in situ, with centering mechanism2316 in a deployed or expanded configuration and a prosthetic heartvalve (not shown) in a delivery or compressed configuration in which theprosthetic heart valve is loaded within a distal capsule section 2302 ofthe delivery system. In this embodiment, centering mechanism 2316includes a plurality of deployable loops 2380 that may be deployedwithin the cusps of the aortic annulus to center distal capsule portion2302 of the delivery system within the native valve annulus for a moresuccessful prosthetic valve deployment. Although centering mechanism2316 is shown with three deployable loops 2380, centering mechanism 2316may include a greater number of deployable loops or a fewer number ofdeployable loops, depending upon application.

In this embodiment, with reference to the cross-sectional view of FIG.23A, in addition to an outer shaft 2306 that defines a lumen 2308 and aninner shaft 2310 that defines a lumen 2312 for receiving a guidewire2314, delivery system 2300 includes an additional concentric outermostshaft 2340. Outer shaft 2306 is positioned within a lumen 2346 definedby outermost shaft 2340. Outermost shaft 2340 is shorter than outershaft 2306, with a distal end 2341 positioned proximal to a proximal endof distal capsule portion 2302. In an embodiment hereof, distal end 2341is positioned between 6-8 cm from a distal end 2304 of delivery system2300 to permit retraction of distal capsule portion 2302. Outermostshaft 2340 includes a proximal hub 2384 mounted or attached to distalend 2341 thereof, and outer shaft 2306 includes a distal hub 2382coupled to an outer surface thereof and positioned proximal to aproximal end of distal capsule portion 2302. Outer and outermost shafts2306, 2340 operate independently such that distal and proximal hubs2382, 2384, respectively, can be independently rotated or translatedlongitudinally relative to one another.

As will be explained in more detail herein, deployable loops 2380 arestraight during advancement of delivery system 2300 into the anatomy andthen are formed into their deployed or expanded in situ by simultaneousrotation and translational displacement thereof. Loops 2380 areindividual or separate strands that extend between proximal and distalhubs 2384, 2382, respectively, with opposing ends of each loop 2380being attached or fixed to one of the hubs. The three deployable loops2380 are circumferentially spaced apart at approximately 120 degreeintervals around outer shaft 2306. In an embodiment, each loop 2380 isinitially formed or provided in a straight or delivery configuration asshown and described with respect to FIG. 24. Stated another way, the lowenergy configuration of each loop 2380 is the straight or deliveryconfiguration of FIG. 24. Once loops 2380 are deployed, a locking orretention mechanism (not shown) may be utilized to maintain the deployedshape thereof until the loops are collapsed for recapture and removal.In another embodiment, each loop 2380 is formed from a self-expandingmaterial such as Nitinol and shape-set in the deployed or expandedconfiguration shown in FIG. 23. Stated another way, in this alternativeembodiment, the low energy configuration of each loop 2380 is thedeployed or expanded configuration shown in FIG. 23. When loops 2380 arestraightened for delivery, a locking or retention mechanism (not shown)may be utilized to maintain the delivery shape thereof until the loopsare released for deployment. For example, the locking mechanism may bepositioned in the handle. In another example, the locking mechanism mayinclude a magnetic element or latch and release element disposed betweenproximal and distal hubs 2384, 2382.

Deployable loops 2380 are integral to delivery system 2300, with theprosthetic heart valve (not shown) being housed within distal capsulesection 2302 which is distal to distal hub 2382 of outer shaft 2306. Theaddition of deployable loops 2380 to the profile of the delivery systemis minimized because deployable loops 2380 are straightened and flushwith the delivery system during delivery and also because deployableloops 2380 are positioned proximal to the prosthetic heart valve ratherthan stacked or in parallel with the prosthetic heart valve. Oncedelivery system 2300 is position as desired, but prior to deployment ofthe prosthetic heart valve, deployable loops 2380 may be deployed andthen positioned in the coronary cusps to provide anatomical and accuratepositioning of delivery system 2300 prior to deployment of theprosthetic heart valve. In particular, since deployable loops 2380 arepositioned in the coronary cusps, centering mechanism 2316 provides bothdepth control as well as rotational alignment in order to properlyposition delivery system 2300. The deployment of loops 2380 aredescribed in more detail with respect to FIGS. 24-28.

More particularly, FIG. 24 is a side view of a portion of outer shaft2306, outermost shaft 2340, and loops 2380, with the components beingshown removed from delivery system 2300 for illustration purposes only.During delivery, loops 2380 are substantially straight and extendbetween proximal and distal hubs 2384, 2382. Stated another way, wheneach loop 2380 is in a delivery configuration, the loop has astraightened profile that is flush against the outer surface of outershaft 2306. When/if proximal and distal hubs 2384, 2382 are rotated withrespect to each other, loops 2380 twist or spiral around outer shaft2306 as shown in FIG. 25. When/if proximal and distal hubs 2384, 2382are translated or moved longitudinally closer to each other, loops 2380bulge or bow radially outwards away from outer shaft 2306 as shown inFIG. 26.

In order to achieve the deployed configuration of loops 2380, proximaland distal hubs 2384, 2382 are simultaneously rotated with respect toeach other and translated or moved longitudinally closer to each other.More particularly, with reference to FIG. 27, proximal and distal hubs2384, 2382 are simultaneously rotated and moved closer together in orderto result in a propeller-like formation or configuration of loops 2380in which loops 2380 both bulge or bow radially outwards away from outershaft 2306 and also are twisted or spiral around outer shaft 2306.Additional rotation and translation result in loops 2380 bending orcurving radially inwards and in a distal direction towards distal hub2382 as shown in FIG. 28. With loops 2380 extending radially inwards andin a distal direction towards distal hub 2382, loops 2380 may bepositioned in the coronary cusps to provide anatomical and accuratepositioning of delivery system 2300 prior to deployment of theprosthetic heart valve. Thus, when each loop 2380 is in an expandedconfiguration, each loop 2380 has a curved, bowed profile radiallyspaced apart from the outer surface of outer shaft 2306 and each loop2380 also spirals with respect to outer shaft 2380.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

What is claimed is:
 1. A delivery system for a valve prosthesisconfigured for delivery within a vasculature, the delivery systemcomprising: an outer shaft defining a lumen and at least two windowsformed through a sidewall thereof; an inner shaft concentricallydisposed within the lumen of the outer shaft, the inner shaft having adistal portion being configured to receive the valve prosthesis thereon;and at least one centering mechanism including at least two wings, afirst end of each wing being attached to the inner shaft and a secondend being free to slide over the inner shaft, wherein when the centeringmechanism is in a delivery configuration each wing is offset from one ofthe windows of the outer shaft and has a straightened profile that isenclosed between the outer and inner shafts and when the centeringmechanism is in an expanded configuration each wing has a curved, bowedprofile and is aligned with and radially extends through one of thewindows of the outer shaft.
 2. The delivery system of claim 1, whereinwhen the centering mechanism is in a delivery configuration each wing iscircumferentially offset from one of the windows of the outer shaft andthe outer shaft is rotated in order to alternate the centering mechanismbetween the delivery configuration and the expanded configuration. 3.The delivery system of claim 1, wherein when the centering mechanism isin a delivery configuration each wing is longitudinally offset from oneof the windows of the outer shaft and the outer shaft is translated inorder to alternate the centering mechanism between the deliveryconfiguration and the expanded configuration.
 4. The delivery system ofclaim 1, wherein the delivery system includes two centering mechanismsdisposed at longitudinally spaced-apart locations along the deliverysystem.
 5. The delivery system of claim 1, wherein the at least onecentering mechanism includes only two wings.
 6. The delivery system ofclaim 1, wherein the at least one centering mechanism includes onlythree wings.
 7. The delivery system of claim 1, wherein the inner shaftincludes at least two longitudinal grooves formed on an outside surfacethereof and each wing is disposed within one of the longitudinalgrooves.
 8. The delivery system of claim 1, wherein when the centeringmechanism is in an expanded configuration the curved, bowed profile ofeach wing extends longitudinally along the outer shaft.
 9. The deliverysystem of claim 1, wherein when the centering mechanism is in anexpanded configuration the curved, bowed profile of each wing extendstransversely around the perimeter the outer shaft.
 10. The deliverysystem of claim 1, wherein each wing is formed from a self-expandingmaterial.
 11. A delivery system for a valve prosthesis configured fordelivery within a vasculature, the delivery system comprising: an outershaft defining a lumen and at least one window formed through a sidewallthereof; an inner shaft concentrically disposed within the lumen of theouter shaft, the inner shaft having a distal portion being configured toreceive the valve prosthesis thereon, wherein the inner shaft isrotatable with respect to the outer shaft; and at least one centeringmechanism including at least one coiled wing, a first end of the coiledwing being attached to the inner shaft and a second end being unattachedto inner shaft, wherein when the centering mechanism is in a deliveryconfiguration the coiled wing has a series of windings that extendaround the inner shaft such that each winding is enclosed between theouter and inner shafts and when the centering mechanism is in anexpanded configuration the coiled wing extends through the window of theouter shaft and has a series of windings that extend around the outershaft.
 12. The delivery system of claim 11, wherein when the centeringmechanism is in an expanded configuration adjacent loops of the coiledwing are spaced apart from each other and not contacting each other inorder to allow blood to flow therebetween.
 13. The delivery system ofclaim 11, wherein the second end of the coiled wing is atraumatic. 14.The delivery system of claim 11, wherein when the centering mechanism isin an expanded configuration adjacent loops of the coiled wing extend ina single plane that is transverse to the outer shaft.
 15. The deliverysystem of claim 11, wherein when the centering mechanism is in anexpanded configuration adjacent loops of the coiled wing longitudinallyextend to form a conical profile.
 16. The delivery system of claim 11,wherein the delivery system includes two centering mechanisms disposedat longitudinally spaced-apart locations along the delivery system. 17.The delivery system of claim 1, wherein the coiled wing is formed from aself-expanding material.
 18. A delivery system for a valve prosthesisconfigured for delivery within a vasculature, the delivery systemcomprising: an outermost shaft defining a central lumen and defining aplurality of lumens in a sidewall thereof; a retractable outer shaftconcentrically disposed within the central lumen of the outermost shaft,the outer shaft defining a lumen; an inner shaft concentrically disposedwithin the lumen of the outer shaft, the inner shaft having a distalportion being configured to receive the valve prosthesis thereon; and aplurality of elongated filaments slidingly positioned within theplurality of lumens of the outermost shaft, each filament having atleast a distal portion formed from a self-expanding material, whereinwhen each elongated filament is in a delivery configuration the distalportion of each elongated filament has a straightened profile that isenclosed within one of the lumens in the sidewall of the outermost shaftand when each elongated filament is in an expanded configuration thedistal portion of each elongated filament has a curved, bowed profileand extends out of a distal end of the outermost shaft.
 19. The deliverysystem of claim 18, wherein the outermost shaft is shorter than theouter shaft and the distal end of the outermost shaft is positionedproximal to a distal end of the outer shaft.
 20. The delivery system ofclaim 19, wherein the distal end of the outermost shaft is flared. 21.The delivery system of claim 18, wherein each elongated filament isindividually deployable.
 22. The delivery system of claim 18, whereinthe distal portion of each elongated filament is more flexible than aproximal portion thereof.
 23. The delivery system of claim 22, whereinwhen each elongated filament is in an expanded configuration the distalportion of each elongated filament curls radially outward andlongitudinally in a proximal direction such that a distal end of eachelongated filament contacts an outer surface of the outermost sheath.24. A delivery system for a valve prosthesis configured for deliverywithin a vasculature, the delivery system comprising: an outermost shaftdefining a central lumen and defining a plurality of lumens in asidewall thereof; a retractable outer shaft concentrically disposedwithin the central lumen of the outermost shaft, the outer shaftdefining a lumen; an inner shaft concentrically disposed within thelumen of the outer shaft, the inner shaft having a distal portion beingconfigured to receive the valve prosthesis thereon; and a plurality ofelongated filaments slidingly positioned within the plurality of lumensof the outermost shaft, a distal end of each elongated filament beingattached to an outer surface of the outer shaft, wherein when eachelongated filament is in a delivery configuration a distal portion ofeach elongated filament has a straightened profile that is flush againstthe outer surface of the outer shaft and when each elongated filament isin an expanded configuration the distal portion of each elongatedfilament has a curved, bowed profile radially spaced apart from theouter surface of the outer shaft.
 25. The delivery system of claim 24,wherein the outermost shaft is shorter than the outer shaft and thedistal end of the outermost shaft is positioned proximal to a distal endof the outer shaft.
 26. A delivery system for a valve prosthesisconfigured for delivery within a vasculature, the delivery systemcomprising: an outer shaft defining a lumen, the outer shaft includingat least one pre-formed deflection segment formed thereon, wherein thedeflection segment has a curved, bowed profile with respect to theremaining length of the outer shaft; and an inner shaft concentricallydisposed within the lumen of the outer shaft, the inner shaft having adistal portion being configured to receive the valve prosthesis thereon,wherein the outer shaft is sufficiently flexible to deform into asubstantially straight configuration when percutaneously introduced intoa vasculature.
 27. A tool for use with a delivery system for a valveprosthesis configured for delivery within a vasculature, the toolcomprising: a shaft component defining a lumen, the shaft componenthaving a proximal end and a distal end; a handle coupled to the proximalend of the shaft component; and a lever arm coupled to the distal end ofthe shaft component, the level arm having a first end attached to anouter surface of the shaft component, wherein when the lever arm is in adelivery configuration the second end of the lever arm is detachablycoupled to the outer surface of the shaft component and the lever armhas a straightened profile that is flush against the outer surface ofthe shaft component and when the lever arm is in an expandedconfiguration the second end of the lever arm is detached from the shaftcomponent and the second end of the lever arm self-expands radially awayfrom the shaft component such that the lever arm forms an acute anglewith respect to the outer surface of the shaft component.
 28. The toolof claim 27, wherein the shaft component is configured to be slidinglypositioned over the delivery system.
 29. The tool of claim 27, whereinthe shaft component is integrated onto the delivery system.
 30. The toolof claim 27, wherein the second end of the lever arm is atraumatic. 31.A delivery system for a valve prosthesis configured for delivery withina vasculature, the delivery system comprising: an outermost shaftdefining a central lumen; an outer shaft concentrically disposed withinthe central lumen of the outermost shaft, the outer shaft defining alumen, wherein the outer shaft is rotatable and slidable relative to theoutermost shaft; an inner shaft concentrically disposed within the lumenof the outer shaft, the inner shaft having a distal portion beingconfigured to receive the valve prosthesis thereon; and a plurality ofdeployable loops, a first end of each loop being attached to a distalend of the outermost shaft and a second end of each loop being attachedto the outer shaft, wherein when each loop is in a deliveryconfiguration the loop has a straightened profile that is flush againstthe outer surface of the outer shaft and when each loop is in anexpanded configuration the loop has a curved, bowed profile radiallyspaced apart from the outer surface of the outer shaft and also spiralswith respect to the outer shaft.
 32. The delivery system of claim 31,wherein the outermost shaft is shorter than the outer shaft and thedistal end of the outermost shaft is positioned proximal to a distal endof the outer shaft.
 33. The delivery system of claim 31, wherein theplurality of deployable loops includes three circumferentially spacedapart deployable loops.
 34. The delivery system of claim 33, whereinwhen in the expanded configuration the three circumferentially spacedapart deployable loops are configured to extend into coronary cusps of anative aortic valve.